BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3080012 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06951
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V515942, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN AN ATTEMPT WAS MADE TO RESET THE PROGRAMMER BECAUSE IT RAN OUT OF BATTERIES. THE PATIENT WAS REPORTEDLY "RELUCTANT" TO HAVE THE PROGRAMMER "TOUCHED AGAIN". THIS WAS NOTED TO HAVE HAPPENED ABOUT A WEEK PRIOR TO THE REPORT. THERE WERE HOWEVER NO ISSUES WITH THE PATIENT'S THERAPY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182621 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1